Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Sr Quality Engineer for a 18 month + Contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment. 

This position is a hybrid between a traditional R&D Engineer and a traditional Quality Engineer.  You will be a key member of the new product development team ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with industry practices. Working closely with R&D, Marketing, Advanced Operations, and Regulatory Affairs team members, you will be in a fast-paced environment with opportunities to win for yourself, the company, and patients around the world.

Position Description (Principle Duties and Responsibilities)

• Representing Quality Assurance on new product development (NPD) cross-functional teams, collaborating across departments to meet development goals.
• Leading risk management activities, including creating and implementing Risk Management Files, identifying potential hazards, and ensuring compliance with corporate and industry regulations.
• Planning, designing, and implementing inspection, testing, and evaluation methods to validate product reliability, including applying advanced statistical methods to determine test sample sizes.
• Leading Design Reviews to ensure design robustness, regulatory compliance (e.g., QSR, ISO 13485), and comprehensive risk analysis for new medical devices.
• Performing and reviewing engineering risk analyses, developing test methods, and driving process improvements to enhance product quality and manufacturing efficiency.
• Providing leadership in product development by interpreting test data, guiding design decisions, and developing protocols for product and process validation.
• Mentoring junior team members, leading departmental initiatives, and influencing cross-functional teams to promote a culture of quality and compliance.
• Interacting with customers to address product quality concerns, delivering quality assurance training, and supporting continuous improvement initiatives

Qualifications: 

• Bachelor's degree in Mechanical, Electrical, Chemical, Material Science, and/or Biomedical Engineering required.
• Minimum of 2+ years' experience in an engineering role.
• Proven ability in data collection, data analysis, and applying the scientific method to solve complex engineering challenges.
• Experience with quality concepts such as Risk Management, CAPA, audits, and statistical techniques is preferred.
• Previous experience in the medical device industry is a plus.
• Familiarity with U.S. and international medical device regulations, including ISO 13485, GDP, and GMP, is preferred.
• Six Sigma Green Belt or ASQ Certified Quality Engineer (CQE) certification is a plus.